MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-15 for AIRSEAL UNK manufactured by Surgiquest,inc..
[40794477]
A correction was made to the original information provide by the user facility in that the fan liver retractor was secured to a book walter instrument holder clamped onto the patient's bed, and was screwed onto the liver retractor as standard practice. The user facility indicated that the device was available for evaluation. However the device could not be located. Good faith efforts to obtain the device have been unsuccessful. Without the actual product an evaluation could not be performed. The model number provided does not exist , but is similar to other model numbers manufactured by surgiquest. The lot number was not provided, because the exact model number and lot number were not provided, a review of the device history record could not be performed. In the event that the device is returned, a follow-up report will be made. The company continues to monitor the clinical use of airseal ifs and works diligently to ensure product safety.
Patient Sequence No: 1, Text Type: N, H10
[40794478]
On (b)(6) 2016, surgiquest was made aware of a purported malfunction with one of its devices via distributor. The event transpired in (b)(6). It was purported that during a minimally invasive total gastrectomy, using a 12mm airseal port, when the trocar was removed a 1x1cm piece of the bottom plastic was missing. The fragment was retrieved from the patient. The user facility submitted the report as a serious injury however reported to surgiquest that the fragment was located quickly and there was no medical intervention or adverse issues to the patient. Additional information reported regarding the event is as follows: "the 12mm airseal access was observed and all appeared normal with the product, a standard covidien fan liver retractor, attached to the robotic arm, was inserted and utilized through the 12mm access port. The fan liver retractor and access port remained fixed in place throughout the entire procedure, but when removed it was noticed that a portion of the distal tip of the 12mm airseal access port was missing". The model number was reported as ias12-120ai.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006217371-2016-00005 |
| MDR Report Key | 5502887 |
| Date Received | 2016-03-15 |
| Date of Report | 2016-02-15 |
| Date of Event | 2016-01-12 |
| Date Mfgr Received | 2016-01-06 |
| Date Added to Maude | 2016-03-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS LORRAINE CALZETTA |
| Manufacturer Street | 488 WHEELERS FARMS ROAD |
| Manufacturer City | MILFORD CT 06461 |
| Manufacturer Country | US |
| Manufacturer Postal | 06461 |
| Manufacturer Phone | 2037992400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AIRSEAL |
| Generic Name | TROCAR |
| Product Code | GCF |
| Date Received | 2016-03-15 |
| Model Number | UNK |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURGIQUEST,INC. |
| Manufacturer Address | 488 WHEELERS FARMS ROAD MILFORD CT 06461 US 06461 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-15 |